Eudamed really becomes operational: what Decision (EU) 2025/2371 changes for medical device manufacturers

Medical devices regulation

01 December 2025

EUDAMED's timetable has long resembled a regulatory conundrum: a demanding regulation, a fragmentary database, modules announced then postponed. On November 26, 2025, the European Commission finally decided. Decision (EU) 2025/2371 officially confirms that several EUDAMED electronic systems are operational and comply with the functional specifications set out in the MDR.
In short, the clock is ticking for manufacturers.

1. What exactly does Decision (EU) 2025/2371 say about EUDAMED?

In accordance with Article 34 of the MDR, the Commission commissioned an independent audit of EUDAMED modules whose development had been finalized. As a result, four systems are now deemed operational and compliant with the functional specifications drawn up in collaboration with the MDCG.

The officially validated modules are:

Stakeholder registrations (SRN)
UDI database & device registration
Notified bodies & certificates
Market surveillance

These four building blocks form the mandatory foundation for the full implementation of EUDAMED. Their validation automatically triggers the transition periods set out in the MDR and IVDR.

2. When does EUDAMED become mandatory for manufacturers?

The Decision comes into force on the day of its publication in the Official Journal. This is an important point: it is this date that marks the start of the regulatory transitions provided for in article 123 MDR and article 113 IVDR.

Not all obligations become effective immediately. They follow deadlines specific to each module, but their starting point is now clear. This puts an end to several years of uncertainty, and imposes on manufacturers a much more structured ramp-up.

The timetable is no longer theoretical. EUDAMED is now an integral part of MDR obligations, not a hypothetical future horizon.

3. What are the concrete new obligations for manufacturers?

EUDAMED is profoundly changing the way manufacturers, authorized representatives, importers and notified bodies interact with the European regulatory system.

Player registration

Obtaining or updating SRN
Consistency between declared data, QMS and technical files

UDI & device registration

Creation and management of Basic UDI-DI
Register devices according to their regulatory status
Continuous updating in the event of significant change

Notified bodies & certificates

Filings, renewals, suspensions, withdrawals: everything becomes traceable and public
Increased harmonization of manufacturer-NB interactions

Market surveillance

Serious incident reporting
Corrective safety actions (FSCA)
Trend monitoring
Integration with internal PMS and vigilance processes

4. Organizational impacts: data, ISO 13485 QMS and governance

The operational implementation of EUDAMED is not an IT issue. It's about data quality, regulation and governance.

Making data reliable

EUDAMED requires perfect consistency between a device's technical, commercial, clinical and regulatory information.
The slightest discrepancy becomes a visible risk of non-compliance.

Adapting the QMS

The following processes need to evolve:

Document control
Vigilance
PMS / PMCF
Change management
Regulatory communication with authorities

Strengthening internal coordination

EUDAMED compliance does not depend on a single department.
It requires alignment between RA/QA, R&D, clinical, supply chain and IT.

5. Two case studies

Case study 1 - Class IIa manufacturer with a large portfolio

The company has several dozen Basic UDI-DIs.
Before EUDAMED, each document update could remain internal. Now, each UDI-DI update becomes a formalized event, integrated into a European regulatory flow.
The main challenge: to industrialize data management and automate interactions with EUDAMED.

Case study 2 - Start-up with a single innovative device

The volume is low, but the regulatory risks remain high.
The startup needs to:

structure its Basic UDI-DI,
formalize a robust PMS as soon as the device is on the market,
secure communication with the notified body,
manage vigilance in EUDAMED without procedural errors.
The main challenge: to professionalize compliance processes without unnecessarily burdening the organization.

6. Mini-FAQ

1. Do I have to use EUDAMED if my device is still under MDD certification?

Yes, EUDAMED obligations are linked to the MDR, but devices in transition are also concerned by registration and surveillance.

2. How do I get my SRN?

Through actor registration, validated by the competent authority. The duration depends on the country.

3. What if my UDI system isn't yet finalized?

This is an immediate priority. The absence of Basic UDI-DI creates a block to registrations.

4. Does EUDAMED replace national obligations?

Gradually, yes. But some national obligations will remain in place during the transition period.

5. Do importers and distributors have to use EUDAMED?

Yes, their traceability and market surveillance obligations are also affected.

A pivotal period for manufacturers

With Decision (EU) 2025/2371, the Commission has at last clarified what the industry has long been waiting for: EUDAMED is no longer a vague project, but a fully-fledged regulatory tool.
For manufacturers, this step marks a change of stance: from a fragmented declarative logic to a structured transparency logic, within a harmonized European framework.

Companies that anticipate the integration of EUDAMED gain in reliability, efficiency and credibility with notified bodies. It's a strategic investment.

Related resources

We're at your service

Do you need to adapt your organization or processes to the EUDAMED upgrade?

CSDmed supports manufacturers in structuring their data, ensuring regulatory compliance and integrating EUDAMED into their QMS.
Let's discuss your situation and define together a realistic and controlled roadmap.